BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    Aurora Surgiscope System

    FDA 510(k)
    FDA Class 2 ·Neurology

    VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025

    STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021

    STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·October 22, 2014

    STERLING ES PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·August 4, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020

    M-VIZION PROXIMAL BODY HANDLE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026

    STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021

    M-VIZION INSERTER ROD

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012